Storage and handling
Proteja el producto del calor excesivo y del sol directo.
CYZONE
- Manufacturer
- Ventura Corporation LTD. | Bel Star S.A. (Colombia) | Yobel Supply Chain Management S.A. (Peru)
- Effective date
- 2013-02-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:41:50
Label at a glance#
ProductCYZONE CY SOLUXION Aclaradora FPS 15
Active ingredientOctinoxate, Oxybenzone
Label structure9 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Información del medicamento
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Ingredientes activos | Propósito |
|---|---|
| Octinoxate 7.5% | Protector solar |
| Oxybenzone 4.5% | Protector solar |
Usos
- Ayuda a prevenir quemaduras solares
Advertencias
Alerta de Cáncer en la piel / envejecimiento de la piel
- Pasar tiempo bajo el sol incrementa el riesgo de cáncer y envejecimiento prematuro de la piel. Este producto ha demostrado que unicamente ayuda a prevenir las quemaduras solares pero no previene el cáncer a la piel ni el envejecimiento prematuro de la misma.
- Sólo para uso externo.
OTC - DO NOT USE SECTION
- No usar en piel dañada o lastimada.
OTC - WHEN USING SECTION
- Cuando use este producto mantener alejado de los ojos.
Enjuagar con agua para eliminar.
OTC - STOP USE SECTION
- Detenga su uso y consulte al doctor si sucede enrojecimiento.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- Mantener fuera del alcance de los niños. Si es ingerido obtener ayuda médica o contactar al centro de Control de Envenenamiento inmediatamente
Instrucciones
- Aplicar generosamente y uniformemente 15 minutos antes de la exposición al sol.
- Reaplicar por lo menos cada dos horas.
- Use un protector solar resistente al agua si usted nada o suda.
- Niños menores a 6 meses de edad: Consulte al médico
Otra información
- Proteja el producto del calor excesivo y del sol directo.
Ingredientes inactivos
Aqua (water), cyclopentasiloxane, glyceryl stearate, c12-15 alkyl benzoate, peg-100 stearate, dicaprylyl carbonate, cetyl alcohol, propylene glycol, glycerin, phenoxyethanol, dimethicone, cyclohexasiloxane, methyl methacrylate crosspolymer, methylparaben, papain, triethanolamine, acrylates/c10-30 alkyl acrylate crosspolymer, ci 77891 (titanium dioxide), propylparaben, parfum (fragrance), castoryl maleate, tetrasodium edta, calcium pantothenate, xanthan gum, caprylyl glycol, urea, butylparaben, magnesium lactate, ethylparaben, ethylhexylglycerin, potassium lactate, isobutylparaben, methylpropanediol, 4-terpineol, alanine, magnesium chloride, proline, serine, sodium citrate, salicylic acid, salix alba bark extract (salix alba (willow) bark extract), arctium majus root extract, citrus limon peel extract (citrus limon (lemon) peel extract ), gentiana lutea root extract, juniperus communis fruit extract, thymus vulgaris (thyme) flower/leaf extract.
SPL UNCLASSIFIED SECTION
Distributed by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton
CREMA
CY
SOLUXION
cy°zone
ACLARADORA
FPS 15
- FAVORECE EL
EMPAREJAMIENTO DEL
TONO DE LA PIEL E
IMPERFECCIONES - AYUDA A PROTEGER DEL
MEDIO AMBIENTE
RECOMENDADO
POR L'BEL
50 g e (1.7 oz.)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13537-449-02 | 2025-04-24 | C162847 | 48780-1 | 9855d018-dcca-cd31-e053-dbdaa90ab51a | CYZONE CREMA CY SOLUXION Aclaradora FPS 15 |
| 13537-449-02 | 2019-11-27 | C162847 | 48780-1 | 9855d018-dcca-cd31-e053-dbdaa90ab51a | CYZONE CREMA CY SOLUXION Aclaradora FPS 15 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| 4-carvomenthenol | INACTIVE INGREDIENT | L65MV77ZG6 | 1 | |
| alanine | INACTIVE INGREDIENT | OF5P57N2ZX | 1 | |
| alkyl (c12-15) benzoate | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| arctium lappa root | INACTIVE INGREDIENT | 597E9BI3Z3 | 1 | |
| butylparaben | INACTIVE INGREDIENT | 3QPI1U3FV8 | 1 | |
| calcium pantothenate | INACTIVE INGREDIENT | 568ET80C3D | 1 | |
| caprylyl glycol | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| cyclomethicone 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| cyclomethicone 6 | INACTIVE INGREDIENT | XHK3U310BA | 1 | |
| dicaprylyl carbonate | INACTIVE INGREDIENT | 609A3V1SUA | 1 | |
| dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| edetate sodium | INACTIVE INGREDIENT | MP1J8420LU | 1 | |
| ethylhexylglycerin | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| ethylparaben | INACTIVE INGREDIENT | 14255EXE39 | 1 | |
| gentiana lutea root | INACTIVE INGREDIENT | S72O3284MS | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| glyceryl monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| isobutylparaben | INACTIVE INGREDIENT | 0QQJ25X58G | 1 | |
| juniper berry | INACTIVE INGREDIENT | O84B5194RL | 1 | |
| lemon peel | INACTIVE INGREDIENT | 72O054U628 | 1 | |
| magnesium chloride | INACTIVE INGREDIENT | 02F3473H9O | 1 | |
| magnesium lactate | INACTIVE INGREDIENT | MT6QI8324A | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| methylpropanediol | INACTIVE INGREDIENT | N8F53B3R4R | 1 | |
| papain | INACTIVE INGREDIENT | A236A06Y32 | 1 | |
| peg-100 stearate | INACTIVE INGREDIENT | YD01N1999R | 1 | |
| phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| potassium lactate | INACTIVE INGREDIENT | 87V1KMK4QV | 1 | |
| proline | INACTIVE INGREDIENT | 9DLQ4CIU6V | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| salicylic acid | INACTIVE INGREDIENT | O414PZ4LPZ | 1 | |
| serine | INACTIVE INGREDIENT | 452VLY9402 | 1 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| thyme | INACTIVE INGREDIENT | CW657OBU4N | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| trolamine | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| urea | INACTIVE INGREDIENT | 8W8T17847W | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| willow bark | INACTIVE INGREDIENT | S883J9JDYX | 1 | |
| xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- CYZONE CY SOLUXION Aclaradora FPS 15
- Octinoxate and Oxybenzone
- Octinoxate
- Oxybenzone
- water
- cyclomethicone 5
- glyceryl monostearate
- alkyl (c12-15) benzoate
- peg-100 stearate
- dicaprylyl carbonate
- cetyl alcohol
- propylene glycol
- glycerin
- phenoxyethanol
- dimethicone
- cyclomethicone 6
- methylparaben
- papain
- trolamine
- titanium dioxide
- propylparaben
- edetate sodium
- calcium pantothenate
- xanthan gum
- caprylyl glycol
- urea
- butylparaben
- magnesium lactate
- ethylparaben
- ethylhexylglycerin
- potassium lactate
- isobutylparaben
- methylpropanediol
- 4-carvomenthenol
- alanine
- magnesium chloride
- proline
- serine
- sodium citrate
- salicylic acid
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13537-449 | 13537-449-01, 13537-449-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, EXTENDED RELEASE / ORAL | 32.4 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | GEL / VAGINAL | 8 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| proline | PROLINE | 9DLQ4CIU6V | INJECTION, SOLUTION / INTRAVENOUS | 0.34 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | CAPSULE / ORAL | NA | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| edetate sodium | EDETATE SODIUM | MP1J8420LU | SHAMPOO / TOPICAL | 1.33 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION, EXTENDED RELEASE / ORAL | 186.8 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| edetate sodium | EDETATE SODIUM | MP1J8420LU | LOTION / TOPICAL | 0.17 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | OINTMENT / TOPICAL | 7 %w/w | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | LOTION / TOPICAL | 4 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAVENOUS | 5 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| cyclomethicone 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | CREAM, AUGMENTED / TOPICAL | 260 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | TABLET / ORAL | 0.2 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / AURICULAR (OTIC) | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SYSTEM / TOPICAL | 42 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | SOLUTION / TOPICAL | NA | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | LOTION / TOPICAL | 0.3 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / VAGINAL | 0.75 %w/w | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 33899f63-8c1a-a574-e063-6394a90a2378 | 8fbeca28-99fd-4899-a9a9-bd9c6b8a6e8c | 2025-04-24 | Warnings | 8fbeca28-99fd-4899-a9a9-bd9c6b8a6e8c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.